research reports and media, page-2067

Keeping up with opioid addiction and drugs to combat it:

https://endpts.com/with-broader-footprint-and-more-dosage-forms-available-recro-announces-a-dive-into-the-opioid-addiction-realm/


Recro takes on big brother role with opioid addiction drug maker, handling manufacturing duties and advising on FDA work.

Josh SullivanAssociate Editor.

Just three weeks ago, CDMO Recro Pharma expanded its footprint to the West Coast, as it acquired San Diego-based Irisys for $50 million cash. The deal helped the company branch out into a broader set of dosage forms — and now that buyout is already bearing fruit.

Recro will serve as both an advisor to BioCorRx in its small molecule development for its opiate addiction treatment drug, dubbed Bicx104, in addition to manufacturing it. The subcutaneous pellet of naltrexone has been given the OK by the FDA to start in-person trials, largely funded by the National Institute on Drug Abuse and the NIH.

It isn’t the company’s first foray into the opioid crisis — in April, Recro announced an agreement with San Diego-based Ensysce — but it will allow the CDMO to use its experience with manufacturing and FDA filings to guide the smaller company.

“This is a perfect example of why Recro sought to acquire and did acquire Irisys, because it allows us to engage in different delivery modalities and thus, widens the market that we can work in,” CEO David Enloe said in a call with Endpoints News. “These are four registration batches with the FDA, it becomes as much about the regulatory and quality findings as it does about the manufacturing, and that’s a place where Recro will bring a lot of resource and a lot of experience there.”

Part of what Recro brings to the table is the heavy lifting to get FDA filings over the goal line. With the Irisys acquisition, the company wanted to expand into different dosage forms. Bicx104 was a way to do just that.

“For us, it was a matter of instilling confidence that the company wasn’t going to be changing direction or adjusting our focus,” Enloe said. “This is a perfect target client for us, it’s a smaller company with a need for a lot of hands-on relationship and trust with us.”

More than 81,000 drug overdose deaths took place between June 2019 and May 2020 in the US alone, according to the CDC, an all-time high. The increase is partially attributed to the Covid-19 pandemic. Bicx104 is an extended-release pellet that delivers naltrexone plasma levels for about three months. It fully biodegrades, which eliminates the need to remove and replace it over time, and has the potential to address alcohol abuse as well. BioCorRx compares the drug to a Russian product named Prodextoxone on its website.

In a statement, BioCorRx CEO Brady Granier said:The exceptional service and support provided through our ongoing CDMO relationship have been critical to BioCorRx’s successful advancement of our implantable naltrexone program. Recro’s recent acquisition of IriSys further bolsters our confidence in our CDMO partnership as we move BICX104 into the clinical stage and a step closer to market for patients battling opioid use disorder, as well as alcohol use disorder.

Now that it has a coast-to-coast presence, Recro is just getting started announcing these types of partnerships, Enloe said.